Manufacturing of cell therapy products.
Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
- Perform manufacturing procedures inside an ISO Class 7 clean room in accordance to established SOPs, cGMPs, and safety regulations.
- Perform aseptic manipulations of cell culture lots and final product assemblies.
- Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
- Input data from production records to existing databases.
- General housekeeping of manufacturing controlled areas.
- Perform clean room equipment sanitization.
- Record equipment metrology readings to ensure the equipment operates within specifications.
- Interact with other departments such as Engineering, Facilities, Materials Management, QA, QC, R&D, Training, and Validation.
- Review completed production records for accuracy.
- Work independently under general supervision and direction.
- Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
- Practice safe work habits and adhere to Vericel’s safety procedures and guidelines. Other duties as assigned.
An ongoing commitment to conducting our business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Biotechnology certificate or equivalent with 0-2 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry, or 3+ years of cGMP experience with GED or equivalent.
- Excellent communication skills, written and verbal.
- Organizational and planning skills and the ability to cooperate with others in a team environment.
- Experience with Microsoft Office.
- Experience working in an ISO 7 clean room environment.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- May be required to sit for long periods of time while performing cell culture operations.
- Must be able to lift, carry, push and pull up to 50 lbs.
- Ability to work 1 weekend day.
- Rotating holiday coverage.
- Ability to gown and gain entry to manufacturing areas.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.